February 2013

Import Licensing for Pharmaceuticals and GMP

Under the Law of Ukraine "On Amendments to the Laws on Licensing of Import of Pharmaceuticals and Definition of an "Active Pharmaceutical Ingredient" (the "Law") import of pharmaceuticals will require a license (the "Import License") starting from 1 March 2013.

According to the Law, pharmaceuticals may be imported only if they have been registered in Ukraine and a manufacturer's quality certificate and import license are in place.

The Import License will be supplemented by the list of pharmaceuticals allowed for import as well as special rules regulating this activity.

The Import License may be issued provided that the applicant possesses appropriate materials and facilities, qualified staff, and is able to exercise quality control over imported pharmaceuticals. The Import Licenses will be issued by the State Inspectorate for Pharmaceuticals (the "Inspectorate").

The licensing requirements were enacted by the Order of Ministry of Health on 20 February 2013 with effect from 1 March 2013.

As from 15 February 2013 all imported pharmaceuticals must comply with international GMP requirements. The Inspectorate is to supervise compliance of Ukrainian and foreign manufacturers with GMP requirements by reviewing relevant documentation.

Importantly, under the Law the licenses for import of active pharmaceutical ingredient will be required starting from 1 January 2015.

For further information please contact partner Oleksandr Padalka
and associate Anna Chornomorets

© Asters 2013
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